REG - Cizzle Biotechnology - Arcadia Clinical Trial Results Published

Cizzle Biotechnology HoldingsAnnouncement

18/08/2022 09:30

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RNS Number : 4617W  Cizzle Biotechnology Holdings PLC  18 August 2022

18 August 2022

 

Cizzle Biotechnology Holdings Plc

 

("Cizzle Biotechnology", "Cizzle" or the "Company")

 

Arcadia Clinical Trial Results Published for Cizzle Biotechnology's Royalty
Bearing interest in AZD1656

 

Cizzle Biotechnology, the UK-based diagnostics developer, is pleased to report
that St George Street Capital ("SGSC") has announced the publication in Lancet
eClinicalMedicine of the results of their Phase 2 clinical trial, ARCADIA.
 The trial investigated AZD1656 for people with diabetes hospitalised with
COVID-19.  As previously announced, Cizzle secured royalty sharing rights for
the commercialisation of AZD1656 for COVID-19 and other indications, including
inflammatory pulmonary and cardiovascular disease.

 

Highlights

 

·    Lancet eClinicalMedicine publishes results of ARCADIA Phase 2
clinical trial on AZD1656 for COVID-19 therapy

·    SGSC progressing commercial discussions with potential pharmaceutical
partners to fund the additional clinical studies required and to bring AZD1656
to the market

·    Cizzle has a significant royalty bearing economic interest in AZD1656
for the treatment of COVID-19, and other diseases including inflammatory
pulmonary and cardiovascular disease

 

eClinicalMedicine is an open access clinical journal published by The Lancet.
It is an internationally trusted source of essential, early evidence in
clinical research.  It has published a paper on the results of the ARCADIA
clinical trial on the use of AZD1656 to treat COVID 19.  Patients in the
AZD1656 arm were observed to have lower mortality; additionally, AZD1656 was
shown to have immunomodulatory capability, as predicted.  The paper also
details their sub-group analysis of patients considered to be at higher risk
of worse COVID-19 outcomes, either with elevated Interleukin 6 (IL-6) or those
with low Vitamin D status.  As surmised in the paper: "the evidence presented
here suggests that specific activation of Tregs might suppress the
inappropriate inflammation which is the prime cause of tissue damage in
autoimmune disease."

 

The full eClinicalMedicine paper may be accessed here:
https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(22)00334-0/fulltext
(https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.thelancet.com%2Fjournals%2Feclinm%2Farticle%2FPIIS2589-5370(22)00334-0%2Ffulltext&data=05%7C01%7Cj.martin%40ucl.ac.uk%7C62c302b7ce994e75b8c808da80e54277%7C1faf88fea9984c5b93c9210a11d9a5c2%7C0%7C0%7C637964019423564373%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=I57P8vxZERUCefoBrS%2FEfuKEfCshYyVB9ceCr64YL70%3D&reserved=0)
.

 

SGSC continues to progress commercial discussions with potential
pharmaceutical partners to fund additional clinical studies, in both Covid-19,
and potentially in further indications, required to bring AZD1656 to the
market with the aim of generating revenues through milestone and or royalty
payments, or by the outright sale of AZD1656.

 

On 14 February 2022, Cizzle announced that it had entered into an agreement
with Conduit Pharmaceuticals Limited ("Conduit"), the commercial partner of
SGSC and SGSC itself, to acquire a 5% uncapped economic interest (after
deductions) in the commercialisation of AZD1656, in addition to its previous
rights, as announced on 20 September 2021, to royalties of up to £5m for the
treatment of COVID-19 and other diseases such as inflammatory pulmonary and
cardiovascular disease.

 

Allan Syms, Executive Chairman of Cizzle Biotechnology, said

 

"The publication of the ARCADIA trial in such a prestigious journal as Lancet
eClinicalMedicine provides a high level of scrutiny to support the evidence
that certain COVID-19 patients could benefit from treatment with AZD1656.
 That it seems to be doing so by acting as an immunomodulator to dampen
inflammatory response suggests it could have wider applications in managing
serious cardiovascular and lung diseases. This aligns with our strategy of
building a portfolio of early detection tests, companion diagnostics and
royalty bearing stakes in significant drug assets and ultimately progress our
ability to earn revenues through royalty sharing rights."

 

Enquiries:

 

 Cizzle Biotechnology Holdings plc  Via IFC Advisory
 Allan Syms (Executive Chairman)

 

 Allenby Capital Limited  +44(0) 20 33285656
 John Depasquale
 Alex Brearley

 

 Novum Securities Limited  +44(0) 20 7399 9400
 Colin Rowbury

 Jon Bellis

 

 IFC Advisory Limited  +44(0) 20 3934 6630
 Tim Metcalfe          cizzle@investor-focus.co.uk
 Florence Chandler

 

Notes to Editors:

About Cizzle Biotechnology

Cizzle Biotechnology is also developing a blood test for the early detection
of lung cancer.  Cizzle Biotechnology is a spin- out from the University of
York, founded in 2006 around the work of Professor Coverley and colleagues.
Its proof-of-concept prototype test is based on the ability to detect a stable
plasma biomarker, a variant of CIZ1 known as CIZ1B.  CIZ1 is a naturally
occurring cell nuclear protein involved in DNA replication, and the targeted
CIZ1B variant is highly correlated with early-stage lung cancer.

For more information, please see https://cizzlebiotechnology.com
(https://cizzlebiotechnology.com)

You can also follow the Company through its twitter account @CizzlePlc and on
LinkedIn.

About SGSC

 

SGSC is a UK-based medical-charity led by a group of highly experienced
academics and ex-pharma executives, that was formed to deliver much needed
treatments to patients. SGSC's strategy is to take clinical-ready assets from
pharmaceutical companies and to progress them through Phase II trials before
licensing them on for Phase III trials and commercialisation, to create a
return for investors and the charity alike

 

For more information please see St George St (sgscapital.org)
(https://sgscapital.org/)

 

About AZD1656

 

AZD1656 was originally developed by AstraZeneca as a diabetes treatment and
has an extensive record of safety in clinical studies involving more than one
thousand subjects.  Preclinical data suggested a likely immune mode of
action, leading SGSC to secure a licence to the agent as a therapy for
inflammatory conditions.

 

In addition to the ARCADIA study supported by Excalibur Medicines Limited, the
Mubadala Sovereign Wealth Fund, Chlodwig Enterprises and UKRI / Innovate UK,
SGSC has actively built on the scope of AZD1656 through patent filing
(COVID-19 combination treatment) and intends to exploit the beneficial
immunomodulatory effect in immune dysfunction applications.

 

Excalibur Medicines Ltd (EML) is a subsidiary of Excalibur Healthcare
Services, founded by leading scientific entrepreneur, Professor Sir Chris
Evans, OBE. EML brought together the scientific intellectual property,
international funding and a world leading team to take forward the ARCADIA
trial.

 

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